BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVITEX POLYPROPYLENE MESH

    MDR report key: 3172274 · Received April 25, 2013

    Report

    Report Number
    1018233-2013-01538
    Event Type
    Injury
    Date Received
    April 25, 2013
    Report Date
    August 1, 2016
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-01377.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180757 PELVITEX POLYPROPYLENE MESH Mesh, surgical, polymeric FTL SOFRADIM PRODUCTION NA PGK00366

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention